Project Management
& Clinical Monitoring
Project Management & Clinical Monitoring
Driving clinical excellence through strategic solutions
With a solid problem-solving mindset, our project team — communicative, experienced, and detail-oriented — ensures that clinical study deliveries are met on time.
Project Management
Compliance
Ensure that protocols, plans, and projects are implemented and executed in accordance with guidelines, legislation, and Standard Operating Procedures (SOPs).
Project Management
Plan, initiate, and manage clinical projects. Monitor the progress of studies according to the management plan and execute quality indicators and goals (KPIs).
Risk assessment and mitigation
Identify risks and develop and implement mitigation plans in collaboration with the team and other stakeholders.
Communication
Act as the main point of contact between the sponsor and the project team members on a daily basis.
Tools and documents
Develop specific study documents and maintain the Trial Master File (TMF) and the Electronic Trial Master File (eTMF).
Resource management
Ensure that the team is adequately trained and that equipment and tools are available for the execution of activities.
Reports
Provide progress reports to the internal team and stakeholders, keeping all parties informed.
Contract Negotiation
Negotiate contracts with research centers, suppliers, and service providers, managing logistics effectively.
Financial control
Manage the project's finances according to the sponsor's contract and budget, ensuring fiscal responsibility.
Compliance
Ensure that protocols, plans, and projects are implemented and executed in accordance with guidelines, legislation, and Standard Operating Procedures (SOPs).
Project Management
Plan, initiate, and manage clinical projects. Monitor the progress of studies according to the management plan and execute quality indicators and goals (KPIs).
Risk assessment and mitigation
Identify risks and develop and implement mitigation plans in collaboration with the team and other stakeholders.
Communication
Act as the main point of contact between the sponsor and the project team members on a daily basis.
Tools and documents
Develop specific study documents and maintain the Trial Master File (TMF) and the Electronic Trial Master File (eTMF).
Resource management
Ensure that the team is adequately trained and that equipment and tools are available for the execution of activities.
Reports
Provide progress reports to the internal team and stakeholders, keeping all parties informed.
Contract Negotiation
Negotiate contracts with research centers, suppliers, and service providers, managing logistics effectively.
Financial control
Manage the project's finances according to the sponsor's contract and budget, ensuring fiscal responsibility.
Compliance
Ensure that protocols, plans, and projects are implemented and executed in accordance with guidelines, legislation, and Standard Operating Procedures (SOPs).
Project Management
Plan, initiate, and manage clinical projects. Monitor the progress of studies according to the management plan and execute quality indicators and goals (KPIs).
Risk assessment and mitigation
Identify risks and develop and implement mitigation plans in collaboration with the team and other stakeholders.
Communication
Act as the main point of contact between the sponsor and the project team members on a daily basis.
Tools and documents
Develop specific study documents and maintain the Trial Master File (TMF) and the Electronic Trial Master File (eTMF).
Resource management
Ensure that the team is adequately trained and that equipment and tools are available for the execution of activities.
Reports
Provide progress reports to the internal team and stakeholders, keeping all parties informed.
Contract Negotiation
Negotiate contracts with research centers, suppliers, and service providers, managing logistics effectively.
Financial control
Manage the project's finances according to the sponsor's contract and budget, ensuring fiscal responsibility.
Compliance
Ensure that protocols, plans, and projects are implemented and executed in accordance with guidelines, legislation, and Standard Operating Procedures (SOPs).
Project Management
Plan, initiate, and manage clinical projects. Monitor the progress of studies according to the management plan and execute quality indicators and goals (KPIs).
Risk assessment and mitigation
Identify risks and develop and implement mitigation plans in collaboration with the team and other stakeholders.
Communication
Act as the main point of contact between the sponsor and the project team members on a daily basis.
Tools and documents
Develop specific study documents and maintain the Trial Master File (TMF) and the Electronic Trial Master File (eTMF).
Resource management
Ensure that the team is adequately trained and that equipment and tools are available for the execution of activities.
Reports
Provide progress reports to the internal team and stakeholders, keeping all parties informed.
Contract Negotiation
Negotiate contracts with research centers, suppliers, and service providers, managing logistics effectively.
Financial control
Manage the project's finances according to the sponsor's contract and budget, ensuring fiscal responsibility.
Compliance
Ensure that protocols, plans, and projects are implemented and executed in accordance with guidelines, legislation, and Standard Operating Procedures (SOPs).
Project Management
Plan, initiate, and manage clinical projects. Monitor the progress of studies according to the management plan and execute quality indicators and goals (KPIs).
Risk assessment and mitigation
Identify risks and develop and implement mitigation plans in collaboration with the team and other stakeholders.
Communication
Act as the main point of contact between the sponsor and the project team members on a daily basis.
Tools and documents
Develop specific study documents and maintain the Trial Master File (TMF) and the Electronic Trial Master File (eTMF).
Resource management
Ensure that the team is adequately trained and that equipment and tools are available for the execution of activities.
Reports
Provide progress reports to the internal team and stakeholders, keeping all parties informed.
Contract Negotiation
Negotiate contracts with research centers, suppliers, and service providers, managing logistics effectively.
Financial control
Manage the project's finances according to the sponsor's contract and budget, ensuring fiscal responsibility.
Data quality and integrity.
Our team of clinical monitors (CRAs), highly qualified and certified in Good Clinical Practices (ICH-GCP), focuses on data integrity, participant safety, and regulatory compliance.
Clinical Monitoring
Clinical Monitoring
Identification, qualification, and selection of research centers
Identification, qualification, and selection of research centers
Preparation and collection of regulatory documents
Preparation and collection of regulatory documents
General contractual negotiation
General contractual negotiation
Management of serious adverse events (SAE) and closing visits
Management of serious adverse events (SAE) and closing visits
Training of the team from the centers
Training of the team from the centers
Remote and in-person monitoring
Remote and in-person monitoring
Control of investigational product and materials
Control of investigational product and materials
A Synvia
Why choose Synvia
With over two decades of experience in clinical trials, bioequivalence, and pharmacovigilance, Synvia combines technology, expertise, and PMI methodology to conduct monitoring with maximum efficiency and traceability.
CRO Services
Other solutions
Discover the other CRO service solutions developed by Synvia
Contact
Talk to our experts
Discover how Synvia can support your studies, analyses, and projects.
Contact
Talk to our experts
Discover how Synvia can support your studies, analyses, and projects.